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Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Primary Purpose

Acute Leukemia of Ambiguous Lineage

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

vincristine

daunorubicin

cyclophosphamide

L-Asparaginase

prednisone

mercaptopurine

methotrexate

dexamethasone

Tyrosine kinase inhibitor

About this trial

This is an interventional treatment trial for Acute Leukemia of Ambiguous Lineage

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged above 14 years with acute leukemia of ambiguous lineage .
Eastern Cooperative Oncology Group (ECOG) Performance status 2.
Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
Patients should sign informed consent form.

Exclusion Criteria:

Impaired cardiac function:
Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (<50 beats per minute); ejection fraction < 45 % on MUGA scan. Corrected QT (QTc) interval > 450 msec on baseline ECG (using the QTcF formula). If QTcF interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
Other concurrent severe and/or uncontrolled medical conditions:
Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
Patients who are: (a) pregnant and (b) breast feeding.

Sites / Locations

HBDH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors.

Outcomes

Primary Outcome Measures

Overall survival (OS)

From the date of diagnosis until the date of death from any cause,

Secondary Outcome Measures

Relapse free survival (RFS)

From the date of CR until the date of relapse or death

The complete remission (CR) rate

Incidence of complete remission after induction chemotherapy

Mortality within 60 days

Proportion of patients died within 60 days

Full Information

NCT ID

NCT04440267

First Posted

June 11, 2020

Last Updated

June 17, 2020

Sponsor

wang, jianxiang

1. Study Identification

Unique Protocol Identification Number

NCT04440267

Brief Title

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Official Title

A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 20, 2020 (Anticipated)

Primary Completion Date

June 20, 2025 (Anticipated)

Study Completion Date

December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

wang, jianxiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukemia of Ambiguous Lineage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

vincristine

Intervention Description